touchEXPERT BRIEFING Apomorphine sublingual film for OFF episodes in Parkinson’s disease
In patients with Parkinson’s disease, an OFF episode typically refers to the recurrence of motor and non-motor symptoms while receiving chronic levodopa-based therapy.1,2 Here we present interviews from two leading experts who review key clinical trial data related to the use of apomorphine sublingual film for the treatment of OFF episodes.
An on-demand therapy for the treatment of OFF episodes in people with Parkinson’s disease
In this interview, Dr. Comella discusses on-demand therapy in Parkinson’s disease and the importance of onset of effect as well as the magnitude and duration of response when treating OFF episodes. Key results from the pivotal study of apomorphine sublingual film as on-demand therapy for OFF episodes (CTH-300) are also presented.
Refer to slides in the Downloads section for more information.
1/3 Next InterviewIn this interview, Dr. Comella answers the following questions:
- What factors can affect the time to onset of efficacy of oral antiparkinsonian medications?
- What is meant by OFF episodes in Parkinson’s disease?
- What is the purpose of on-demand therapy?
- What is the proposed mechanism of action of apomorphine?
- What is APL?
- Based on the results of the pivotal study (CTH-300), when did patients experience an onset of effect with apomorphine sublingual film and how long did the effects last?
- How does the onset, magnitude, and duration of effect with APL compare with those of levodopa based on a post-hoc analysis?
Cynthia Comella is Professor of Neurological Sciences at Rush University Medical Center in Chicago, Illinois. She is an active committee member of the Movement Disorders Society and the American Academy of Neurology (AAN), and serves on the editorial board of Continuum and the Board of Directors of the AAN institute. Her research on Parkinson’s disease includes evaluating new therapies and examining the effects of exercise. Dr. Comella is also an author or co-author of more than 165 articles, reviews, research papers, books, and book chapters about various topics relating to movement disorders, including Parkinson’s disease.
Disclosures: Dr. Comella is a paid consultant for Sunovion Pharmaceuticals Inc. She also serves on the editorial board of Clinical Neuropharmacology and Sleep Medicine. She has received compensation/honoraria for services as a consultant or an advisory committee member from: Acadia Pharmaceuticals; Acorda Therapeutics; AEON Biopharma; Allergan, Inc; Ipsen Pharmaceuticals; Jazz Pharmaceuticals; Lundbeck Ltd; Merz Pharmaceuticals; Neurocrine Biosciences Inc; Revance Therapeutics Inc. She also receives royalties from Cambridge University Press and Wolters Kluwer.
Self-administration of APL per patient diaries for the treatment of OFF episodes in people with Parkinson’s disease
In this interview, Dr. Hauser discusses the self-administration of apomorphine sublingual film (APL) as on-demand therapy for OFF episodes per patient home dosing and response diaries in the pivotal study (CTH-300).
Refer to slides in the Downloads section for more information.
2/3 Next InterviewIn this interview, Dr. Hauser answers the following questions:
- How was self-administration of APL assessed in the CTH-300 study?
- What was learned from the home dosing and response diaries in the CTH-300 study, considering their limitations?
- What adverse events were seen with the use of APL?
Robert A. Hauser is Director of the Parkinson’s disease and Movement Disorders Center of Excellence and Professor of Neurology at the University of South Florida in Tampa, USA. He has also served on the Executive Committee of the Parkinson Study Group and chaired the American Academy of Neurology Section on Interventional Neurology. Dr. Hauser’s research focuses on the development of new medical and surgical therapies for Parkinson’s disease and other movement disorders. He has served as National Principal Investigator on multiple studies, has participated in over 200 clinical trials, and has authored or co-authored over 300 peer-reviewed publications.
Disclosures: Dr. Hauser is a paid consultant for Sunovion Pharmaceuticals Inc. He has also acted as a consultant for Acadia Pharmaceuticals, Acorda Therapeutics, Adamas Pharmaceuticals, Affiris, AlphaSights, Amneal Pharmaceuticals, ApoPharma, Aptinyx, Aranca, Axovant, Britannia, Cadent, CAVR, Cerevel Therapeutics, ClearView Healthcare Partners, Clinical Score LLC, CNS Ratings LLC, Compass Group, Curium Pharma, Decision Resource Group (DRG), Dedham Group, Defined Health, Denali, Enterin, Extera Partners, F. Hoffmann-La Roche Ltd., First Word, Gerson Lehman Group (GLG), Global Kinetics Consulting (GKC), Global Life Sciences, Guidepoint Global, Huron, Impax Laboratories, Impel Neuropharma, Inhibikase, InSearch Consulting, Insignia Strategies, In-Trace Medical Systems, ISCO, IQVIA, Jazz Pharmaceuticals, Kaiser Permanente, Kashiv Pharma, KeiferRX LLC, KeyQuest, KX Advisors, Kyowa Kirin Pharmaceuticals, L.E.K Consulting, LifeSciences Consultants, Lundbeck A/S, Medscape, MJFF, MPTA, Neuro Challenge Foundation for PD, Neurocrine Biosciences, NeuroDerm, NOVUS, Orion, Parkinson Study Group, Pennside Partners, Perception OpCo, Pharmather, PSL Group, Regenera Pharma, Research Catalyst, Revance Therapeutics, Schlesinger Associates, Scion NeuroStim LLC, Seelos Therapeutics, Slingshot Insights, Supernus Pharma, Teva Pharmaceuticals, Tolmar Inc, and US World Meds. He has also received research support from AbbVie, Axovant Sciences Ltd, Biogen Inc, Biotie Therapies Inc, Cavion, Inc, Centogene, Cerevance, Cerevel Therapeutics Inc, Civitas Therapeutics Inc, Cynapsus Therapeutics, Enterin Inc, F. Hoffman-La Roche Ltd, Global Kinetics Corporation (GKC), Impax Laboratories, Intec Pharma, Jazz Pharmaceuticals, Michael J Fox Foundation, Neuraly, NeuroDerm Ltd, Northwestern University, Pfizer, Pharma Two B, Revance Therapeutics, Sanofi US Services Inc, Sun Pharma Advanced Research Company and Sunovion Pharmaceuticals Inc. Dr. Hauser has participated in Scientific Advisory Boards or Panels for Inhibikase, Impel Neuro Pharma, and Cerespir, as well as Speaker Bureau activities for Acorda Therapeutics, Adamas Pharmaceuticals, Amneal Pharmaceuticals, Kyowa Kirin Pharmaceuticals, Neurocrine Biosciences, Sunovion Pharmaceuticals, and US World Meds. He holds stocks or shares in Inhibkase and Axial Therapeutics, and receives royalties/holds patents relating to the USF PD Diary.
Safety of APL for the treatment of OFF episodes in people with Parkinson’s disease
In this interview, Dr. Hauser discusses select safety data from the pivotal study (CTH-300) and an ongoing open-label study (CTH-301) of apomorphine sublingual film as on-demand therapy for OFF episodes.
Refer to slides in the Downloads section for more information.
3/3 Leave FeedbackIn this interview, Dr. Hauser answers the following questions:
- What rates of nausea were seen with APL?
- What is the impact of APL on dyskinesia rates?
- How does APL affect impulse control or compulsive disorders?
Robert A. Hauser is Director of the Parkinson’s disease and Movement Disorders Center of Excellence and Professor of Neurology at the University of South Florida in Tampa, USA. He has also served on the Executive Committee of the Parkinson Study Group and chaired the American Academy of Neurology Section on Interventional Neurology. Dr. Hauser’s research focuses on the development of new medical and surgical therapies for Parkinson’s disease and other movement disorders. He has served as National Principal Investigator on multiple studies, has participated in over 200 clinical trials, and has authored or co-authored over 300 peer-reviewed publications.
Disclosures: Dr. Hauser is a paid consultant for Sunovion Pharmaceuticals Inc. He has also acted as a consultant for Acadia Pharmaceuticals, Acorda Therapeutics, Adamas Pharmaceuticals, Affiris, AlphaSights, Amneal Pharmaceuticals, ApoPharma, Aptinyx, Aranca, Axovant, Britannia, Cadent, CAVR, Cerevel Therapeutics, ClearView Healthcare Partners, Clinical Score LLC, CNS Ratings LLC, Compass Group, Curium Pharma, Decision Resource Group (DRG), Dedham Group, Defined Health, Denali, Enterin, Extera Partners, F. Hoffmann-La Roche Ltd., First Word, Gerson Lehman Group (GLG), Global Kinetics Consulting (GKC), Global Life Sciences, Guidepoint Global, Huron, Impax Laboratories, Impel Neuropharma, Inhibikase, InSearch Consulting, Insignia Strategies, In-Trace Medical Systems, ISCO, IQVIA, Jazz Pharmaceuticals, Kaiser Permanente, Kashiv Pharma, KeiferRX LLC, KeyQuest, KX Advisors, Kyowa Kirin Pharmaceuticals, L.E.K Consulting, LifeSciences Consultants, Lundbeck A/S, Medscape, MJFF, MPTA, Neuro Challenge Foundation for PD, Neurocrine Biosciences, NeuroDerm, NOVUS, Orion, Parkinson Study Group, Pennside Partners, Perception OpCo, Pharmather, PSL Group, Regenera Pharma, Research Catalyst, Revance Therapeutics, Schlesinger Associates, Scion NeuroStim LLC, Seelos Therapeutics, Slingshot Insights, Supernus Pharma, Teva Pharmaceuticals, Tolmar Inc, and US World Meds. He has also received research support from AbbVie, Axovant Sciences Ltd, Biogen Inc, Biotie Therapies Inc, Cavion, Inc, Centogene, Cerevance, Cerevel Therapeutics Inc, Civitas Therapeutics Inc, Cynapsus Therapeutics, Enterin Inc, F. Hoffman-La Roche Ltd, Global Kinetics Corporation (GKC), Impax Laboratories, Intec Pharma, Jazz Pharmaceuticals, Michael J Fox Foundation, Neuraly, NeuroDerm Ltd, Northwestern University, Pfizer, Pharma Two B, Revance Therapeutics, Sanofi US Services Inc, Sun Pharma Advanced Research Company and Sunovion Pharmaceuticals Inc. Dr. Hauser has participated in Scientific Advisory Boards or Panels for Inhibikase, Impel Neuro Pharma, and Cerespir, as well as Speaker Bureau activities for Acorda Therapeutics, Adamas Pharmaceuticals, Amneal Pharmaceuticals, Kyowa Kirin Pharmaceuticals, Neurocrine Biosciences, Sunovion Pharmaceuticals, and US World Meds. He holds stocks or shares in Inhibkase and Axial Therapeutics, and receives royalties/holds patents relating to the USF PD Diary.
Overview & Learning Objectives
Overview
Watch two leading experts discuss the use of apomorphine sublingual film to treat OFF episodes in Parkinson’s Disease. In the first interview, Dr. Cynthia Comella discusses the purpose of on-demand therapy in Parkinson’s disease and the importance of onset of effect when treating OFF episodes. In the second interview, Dr. Robert A. Hauser discusses the self-administration of apomorphine sublingual film in the pivotal study (CTH-300) based on home dosing and response diaries. Lastly, Dr. Robert A. Hauser discusses safety data from a pivotal study and an open-label study of apomorphine sublingual film as on-demand therapy for OFF episodes (studies CTH-300 and CTH-301).
Learning Objectives
After watching this activity, participants should be better able to:
- Understand what is meant by OFF episodes in Parkinson’s disease and the purpose of on-demand therapy
- Understand the importance of onset of effect as well as the magnitude and duration of response when treating OFF episodes in Parkinson’s disease
- Describe key safety and efficacy data from the pivotal study (CTH-300) and the long-term, open-label (CTH-301) study of apomorphine sublingual film for OFF episodes in Parkinson’s disease
References
- Chou K. The spectrum of OFF in Parkinson’s disease: What have we learned over 40 years? Park Rel Disord. 2018;51:9–16.
- Storch A, Schneider CB, Wolz M, et al. Nonmotor fluctuations in Parkinson disease: severity and correlation with motor complications. Neurology. 2013;80:800–9.
- Olanow CW, et al. Efficacy, safety and tolerability study of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson’s disease. Lancet Neurol. 2020;19:135-144. [NCT024609090].
- Hui JS, et al. Open-label titration of apomorphine sublingual film in patients with Parkinson’s disease and OFF episodes. Parkinsonism Relat Disord 2020;79:110–116.
- NIH US National Library of Medicine. Clinicaltrials.gov: Open-label phase 3 study to examine the long-term safety, tolerability, and efficacy of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease. Available from: https://www.Clinicaltrials.gov/ct2/show/NCT02542696
- Factor S, et al. Presented at: International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2020; September 12-16, 2020. Abstract 888.
- Hauser RA, Mehta SH, Blum D, et al. Patient-reported motor responses to apomorphine sublingual film on home dosing and response diaries. Abstract 141; presented at 3rd Pan American Parkinson’s disease and Movement Disorders Congress (MDS-PAS), February 14–16, 2020; Miami, Florida, United States.
- Ellenbogen AL, Nicholas AP, Hauser RA, et al. Apomorphine sublingual film for the treatment of “OFF” episodes in patients with Parkinson’s disease: impact of concomitant antiemetics and dopamine agonists on nausea and vomiting. Presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress, September 12–16, 2020. Abstract 883.
- Klos KJ, Hui JS, Robottom BJ, et al. Apomorphine sublingual film for the treatment of “OFF” episodes in patients with Parkinson’s disease: impact on dyskinesia. Presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress, September 12–16, 2020.
- Espay AJ, et al. Apomorphine sublingual film for the treatment of “OFF” episodes in patients with Parkinson’s disease: impact on impulse control disorders. Presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress, September 12–16, 2020.